Fluid collecting sheaths for endoscopic devices and systems

ABSTRACT

A system includes an endoscope defining a proximal end, a distal end and an elongated shaft extending between the proximal end and the distal end of the endoscope. A fluid collecting sheath defines a proximal end and a distal end. The fluid collecting sheath is configured for insertion into a vaginal opening. The fluid collecting sheath includes fluid collecting apertures defined at the distal end of the fluid collecting sheath. A fluid line is in fluid communication with the fluid collecting apertures. A channel is formed in the fluid collecting sheath. The channel extends between the proximal end and the distal end of the fluid collecting sheath. The channel defines an opening therein. The channel of the fluid collecting sheath is configured to operably engage the elongated shaft of the endoscope by passing the elongated shaft of the endoscope through the opening of the channel.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. application Ser. No. 16/778,292, filed on Jan. 31, 2020, the entire contents of which being incorporated by reference herein.

BACKGROUND Technical Field

The present disclosure relates to surgical instruments and, more particularly, to fluid collecting sheaths for endoscopic devices and systems.

Discussion of Related Art

Tissue resection may be performed endoscopically within an organ, such as a uterus, by inserting an endoscope (or hysteroscope) into the uterus and passing a tissue resection instrument through the endoscope (or hysteroscope) and into the uterus. With respect to such endoscopic tissue resection procedures, it often is desirable to distend the uterus with a fluid, for example, saline, sorbitol, or glycine. The inflow and outflow of the fluid during the procedure maintains the uterus in a distended state and flushes tissue and other debris from within the uterus to maintain a visible working space.

During a tissue resection procedure, for example, a pressure differential may cause fluid to leak out of the uterus through the opening through which the endoscope is inserted. Leaking fluid may travel down the length of the endoscope and drip onto the physician or the floor, presenting a hazard.

SUMMARY

In accordance with an aspect of the present disclosure, a system includes an endoscope defining a proximal end, a distal end and an elongated shaft extending between the proximal end and the distal end of the endoscope. A fluid collecting sheath defines a proximal end and a distal end. The fluid collecting sheath is configured for insertion into a vaginal opening. The fluid collecting sheath includes fluid collecting apertures defined at the distal end of the fluid collecting sheath. A fluid line is in fluid communication with the fluid collecting apertures. A channel is formed in the fluid collecting sheath. The channel extends between the proximal end and the distal end of the fluid collecting sheath. The channel defines an opening therein. The channel of the fluid collecting sheath is configured to operably engage the elongated shaft of the endoscope by passing the elongated shaft of the endoscope through the opening of the channel.

In some aspects, the channel of the fluid collecting sheath fixedly engages the elongated shaft of the endoscope. The fluid collecting sheath and the endoscope move in concert with one another.

In some aspects, at least one drip flange is formed at the distal end of the fluid collecting sheath. The at least one drip flange directs fluid away from the channel of the fluid collecting sheath.

In some aspects, the system includes a collection vessel in fluid communication with the fluid line. The collection vessel receives fluid captured by the fluid collecting apertures.

In some aspects, a collar extends from the fluid line. The collar is configured to be secured to the endoscope. The collar may be at least partially elastic.

In some aspects, the fluid collecting sheath and the fluid line are a single integrally formed structure in which the fluid line extends within the fluid collecting sheath between the proximal end and the distal end of the fluid collecting sheath.

In some aspects, the opening of the channel is formed through an outer edge of the fluid collecting sheath.

In some aspects, the channel is configured to selectively expand in width.

In some aspects, the system includes a vacuum source in fluid communication with the fluid line. The vacuum source applies negative pressure to the fluid collecting apertures to draw fluid through the fluid line.

In some aspects, a single fluid collecting aperture may be defined at the distal end of the fluid collecting sheath.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate aspects and features of the present disclosure and, together with the detailed description below, serve to further explain the present disclosure, in which:

FIG. 1 shows an endoscopic system in accordance with the present disclosure;

FIG. 2 is a side view of a fluid collecting sheath in accordance with the present disclosure;

FIG. 3 illustrates the fluid collecting sheath of FIG. 2 positioned between vaginal walls of a patient with the endoscope of FIG. 1 extending through the fluid collecting sheath;

FIG. 4 is a top plan view of another fluid collecting sheath in accordance with the present disclosure positioned between vaginal walls of a patient;

FIG. 5 is a perspective view of the fluid collecting sheath of FIG. 4 ;

FIG. 6 is a side view of a fluid line having a collar in accordance with the present disclosure; and

FIG. 7 is a top plan view of another fluid collecting sheath in accordance with the present disclosure.

DETAILED DESCRIPTION

As used herein, the term “distal” refers to the portion that is being described which is further from a user, while the term “proximal” refers to the portion that is being described which is closer to a user. Further, to the extent consistent, any of the aspects and features detailed herein may be used in conjunction with any or all of the other aspects and features detailed herein.

Descriptions of technical features or aspects of an exemplary endoscopic system of the present disclosure should typically be considered as available and applicable to other similar features or aspects in another exemplary endoscopic system of the present disclosure. Accordingly, technical features described herein according to one exemplary endoscopic system of the present disclosure may be applicable to other exemplary endoscopic systems of the present disclosure, and thus duplicative descriptions may be omitted herein.

Exemplary endoscopic systems of the present disclosure will be described more fully below (e.g., with reference to the accompanying drawings). Like reference numerals may refer to like elements throughout the specification and drawings.

The endoscope described herein may be a hysteroscope.

FIG. 1 shows an example endoscopic system 100 that includes an endoscopic device 104 including an elongated shaft 128 extending between a proximal end 126 and a distal end 124 of the endoscopic device 104. In the example, the endoscopic device 104 is connected to a fluid pump 106 and a fluid reservoir 112 (such as a saline bag) by way of a fluid line 108 that is coupled to a fluid port 120. The fluid pump 106 may be fluidly coupled to a separate fluid reservoir 112, or alternatively the fluid pump 106 may include a fluid reservoir. The fluid pump 106 may be a peristaltic pump, a positive displacement pump, or a centrifugal pump, any of which may be employed to generate fluid inflow (e.g., via negative pressure). Alternatively, the fluid pump 106 may be omitted and the fluid reservoir 112 may be in direct fluid communication with the fluid port 120, e.g., to provide fluid inflow via gravity. The endoscopic device 104 may further include optics, e.g., lenses and/or image capture electronics, together with an illumination source to enable visualization of a field of view emanating from distal end 124. The endoscopic device 104 may additionally or alternatively include a working channel to enable insertion of a working instrument, e.g., a resection device, through the endoscope 104 and into a surgical site. Alternatively, the endoscopic device 104 may itself be a working instrument.

In a hysteroscopy procedure, for example, the distal end 124 of endoscopic device 104 is inserted transvaginally through a patient's cervix and into the patient's uterus. The patient's cervix may expand circumferentially to accommodate the endoscopic device 104, and effectively create a seal about the endoscopic device 104. During a hysteroscopy, fluid (e.g., pressurized fluid) may leak from the uterus 311 (or uterus 411 in FIG. 4 ) through the cervix (see, e.g., cervix 313 in FIG. 3 or cervix 413 in FIG. 4 ) to a patient's vaginal area. Leaking fluid may be collected in an under-buttocks drape, which is positioned between the patient's legs. However, the drape's function depends on correct placement of the drape throughout the procedure, and thus fluid often escapes capture.

FIGS. 2 and 3 show a fluid collecting sheath 200 in accordance with one aspect of the present disclosure. An endoscopic instrument, e.g., endoscope 304, extends through a proximal orifice 220 at a proximal end 216 of the fluid collecting sheath 200 such that a distal end 324 of the endoscope 304 extends through a patient's vagina 310 and cervix 314 and into the patient's uterus 311. The endoscope 304 may be substantially the same as the endoscopic device 104 described with reference to FIG. 1 .

A fluid line 202 extends from a distal end 214 of the fluid collecting sheath 200. The fluid line 202 forms a fluid drain 221 at the distal end 214 of the fluid collecting sheath 200. The fluid drain 221 is configured to drain fluid leaking through the patient's cervix 313 and passed into the patient's vagina 310. The suction or drain line 202 may be in fluid communication with a collection vessel 230. A vacuum source 240 may create negative pressure in the fluid line 202 to draw fluid into the fluid drain 221 or the fluid line 202 may transport fluid from the fluid collection sheath 200 to the collection vessel 230 under gravity.

An outer edge 212 of the fluid collecting sheath 200 is flexible to conform to and create a seal against walls of a patient's vagina 310 and, in some cases, about the cervix 313. The outer edge 212 is collapsible for insertion into the vagina 310. The outer edge 212 of the fluid collecting sheath 200 may act as a vaginal retractor to allow visualization of the patient's cervix 313 through the proximal orifice 220. The fluid collecting sheath 200 may taper in diameter in a distal-to-proximal direction.

The proximal orifice 220 may be flexible to expand and contract to various diameters to receive various sized elongated shafts 328 therein. The proximal orifice 220 may be dimensioned such that the endoscope 304 can move independently of the fluid collecting sheath 200. Alternatively, the fluid collecting sheath 200 may be removable, but securely fixed to the elongated shaft 328 of the endoscope 304, e.g., under resilient and/or friction fit engagement.

FIGS. 4 to 6 show a surgical system including a fluid collecting sheath 400 in accordance with one aspect of the present disclosure. The system includes an endoscope 404 defining a proximal end 426, a distal end 424 and an elongated shaft 428 extending between the proximal end 426 and the distal end 424 of the endoscope 404. The endoscope 404 may be substantially the same as the endoscopic device 104 described with reference to FIG. 1 .

The fluid collecting sheath 400 defines a proximal end 416 and a distal end 414. The fluid collecting sheath 400 is configured for insertion into a vaginal opening 410. In use, the fluid collecting sheath 400 is inserted distal end 414 first. The fluid collecting sheath 400 includes fluid collecting apertures 421 defined at the distal end 414 of the fluid collecting sheath 400. A single fluid collecting aperture 421 or a plurality of fluid collecting apertures 421 may be defined at the distal end 414 of the fluid collecting sheath 400. A fluid line 402 is in fluid communication with the fluid collecting apertures 421. The fluid collecting apertures 421 are each positioned at a lower portion of the fluid collecting sheath 400 such that gravity directs fluid toward the fluid collecting apertures 421.

The fluid collecting apertures 421 may be positioned at a side of the fluid collecting sheath 400 substantially opposite from channel 403. As an example, the fluid collecting apertures 421 may be positioned at a lower portion of the fluid collecting sheath 400 such that gravity directs fluids toward the fluid collecting apertures 421. Fluid may additionally be pulled toward and drawn into the fluid collecting apertures 421 through negative pressure created in the fluid line 402 (e.g., by vacuum source 440).

A channel 403 is formed in the fluid collecting sheath 400. The channel 403 defines a substantially circular cross-sectional shape. The channel 403 extends between the proximal end 416 and the distal end 414 of the fluid collecting sheath 400. The channel 403 defines an elongated opening 405 therein along the length thereof. The opening 405 may be formed at an outer edge (e.g., an upper portion) of the fluid collecting sheath 400. The opening 405 is configured to allow the elongated shaft 428 of the endoscope 404 to pass transversely therethrough. The channel 403 of the fluid collecting sheath 400 is configured to operably engage the elongated shaft 428 of the endoscope 404 by passing the elongated shaft 428 of the endoscope 404 transversely through the opening 405 of the channel 403. Radial inward pressure may be applied to the elongated shaft 428 by the sidewalls defining the channel 403.

The channel 403 of the fluid collecting sheath 400 fixedly engages the elongated shaft 428 of the endoscope 404. The fluid collecting sheath 400 and the endoscope 404 move substantially in concert with one another. For example, advancing the endoscope 404 to distally advance the distal end 424 of the elongated shaft 428 will result in a corresponding distal advancement of the fluid collecting sheath 400. Alternatively, the fluid collecting sheath 400 may be configured to enable the endoscope 404 to move independently of the fluid collecting sheath 400.

The channel 403 is configured to selectively expand in width to accommodate and operatively connect with elongated shafts of endoscopes having various widths or diameters.

At least one drip flange (e.g., drip flanges 406 and/or 407) may be formed at the distal end 414 of the fluid collecting sheath 400. The at least one drip flange directs fluid away from the channel 403 of the fluid collecting sheath 400. For example, the at least one drip flange may be distally extending lip extending distally from the distal end 414 of the fluid collecting sheath 400. The distally extending lip including drip flanges 406 and 407 may extend distally around a distal end 434 of the channel 403, thus directing water away from the channel 403 and toward the fluid collecting apertures 421.

A collection vessel 430 is in fluid communication with the fluid line 402. The collection vessel 430 receives fluid captured by the fluid collecting apertures 421 after the captured fluid has passed through the fluid line 402.

The fluid collecting sheath 400 and the fluid line 402 may be a single integrally formed structure in which the fluid line 402 extends within the fluid collecting sheath 400 between the proximal end 416 and the distal end 414 of the fluid collecting sheath (see, e.g., FIG. 5 ).

A vacuum source 440 may be in fluid communication with the fluid line 402. The vacuum source 440 may be connected with the collection vessel 430 to apply negative pressure to the fluid line 402 therethrough (see, e.g., FIG. 4 ). Alternatively, the vacuum source 440 may be connected directly with the fluid line 403. The vacuum source 440 applies negative pressure to the fluid collecting apertures 421 via the fluid line 402 to draw fluid into and through the fluid line 402. The vacuum source 440 may in some embodiments be a peristaltic pump, a positive displacement pump, or a centrifugal pump, any of which may be employed to generate fluid inflow (e.g., via negative pressure). Alternatively, fluid may be transported through fluid line 402 under gravity.

According to one aspect of the disclosure, the fluid collecting sheath 400 can be removably coupled to the endoscope 404. For example, in use, the endoscope 404 may be inserted into a vaginal opening 410 prior to the insertion of the fluid collecting sheath 400. Subsequently, the fluid collecting sheath 400 may be inserted into the vaginal opening 410 and then removably coupled to the elongated shaft 428 of the endoscope 404 to secure the fluid collecting sheath 400 to the endoscope 404 without the need to remove the endoscope 404. This may be achieved by applying pressure to the fluid collecting sheath 400 to force the elongated shaft 428 of the endoscope 404 transversely into the channel 403 through opening 405. The fluid collecting sheath 400 may include or be formed of a material (e.g., a flexible polymer) allowing sufficient bending to allow opening 405 to open sufficiently to allow elongated shaft 428 of the endoscope 404 to be securely forced into channel 403. Thus, during use the fluid collecting sheath 400 may remain substantially fixed to the endoscope 404. The fluid collecting sheath 400 may also be decoupled from the elongated shaft 428 of the endoscope 404 and removed without the need to remove the endoscope 404 by reversing the attachment steps described above. Thus, the fluid collecting sheath 400 may be introduced or removed as needed without the need to also remove the endoscope 404.

Referring particularly to FIG. 6 , a collar 650 extends from a fluid line 602. The fluid line 602 may be substantially the same as fluid line 402 described herein (FIG. 4 ). The collar 650 is configured to be secured to an endoscope (e.g., to an elongated shaft 428 of endoscope 404 (FIG. 4 )). The collar 650 may be at least partially elastic. The fluid line 602 may connect with fluid collecting apertures 621. Fluid collecting apertures 621 may be substantially the same as fluid collecting apertures 421 described herein (see FIG. 4 ).

FIG. 7 shows a fluid collecting sheath 700 having a proximal end 716 and a distal end 714. Fluid collecting sheath 700 may be substantially the same as fluid collecting sheath 400 described herein, except that fluid collecting sheath 700 may have a tapered proximal end 716. For example, a width of the fluid collecting sheath 700 when viewed from a top plan view may narrow gradually from the distal end 714 to the proximal end 716. The tapered distal end 716 may allow for easier grasping by a surgical instrument to remove fluid collecting sheath 700 from a vaginal opening.

The various endoscopic systems disclosed herein may also be configured to work with robotic surgical systems and what is commonly referred to as “Telesurgery.” Such systems employ various robotic elements to assist the surgeon and allow remote operation (or partial remote operation) of surgical instrumentation. Various robotic arms, gears, cams, pulleys, electric and mechanical motors, etc. may be employed for this purpose and may be designed with a robotic surgical system to assist the surgeon during the course of an operation or treatment. Such robotic systems may include remotely steerable systems, automatically flexible surgical systems, remotely flexible surgical systems, remotely articulating surgical systems, wireless surgical systems, modular or selectively configurable remotely operated surgical systems, etc.

The robotic surgical systems may be employed with one or more consoles that are next to the operating theater or located in a remote location. In this instance, one team of surgeons or nurses may prep the patient for surgery and configure the robotic surgical system with one or more of the instruments disclosed herein while another surgeon (or group of surgeons) remotely control the instruments via the robotic surgical system. As can be appreciated, a highly skilled surgeon may perform multiple operations in multiple locations without leaving his/her remote console which can be both economically advantageous and a benefit to the patient or a series of patients.

The robotic arms of the surgical system are typically coupled to a pair of master handles by a controller. The handles can be moved by the surgeon to produce a corresponding movement of the working ends of any type of surgical instrument (e.g., end effectors, graspers, knifes, scissors, etc.) which may complement the use of one or more of the endoscopic system s described herein. The movement of the master handles may be scaled so that the working ends have a corresponding movement that is different, smaller or larger, than the movement performed by the operating hands of the surgeon. The scale factor or gearing ratio may be adjustable so that the operator can control the resolution of the working ends of the surgical instrument(s).

The master handles may include various sensors to provide feedback to the surgeon relating to various tissue parameters or conditions, e.g., tissue resistance due to manipulation, cutting or otherwise treating, pressure by the instrument onto the tissue, tissue temperature, tissue impedance, etc. As can be appreciated, such sensors provide the surgeon with enhanced tactile feedback simulating actual operating conditions. The master handles may also include a variety of different actuators for delicate tissue manipulation or treatment further enhancing the surgeon's ability to mimic actual operating conditions.

From the foregoing and with reference to the various figure drawings, those skilled in the art will appreciate that certain modifications can also be made to the present disclosure without departing from the scope of the same. While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto. 

1-20. (canceled)
 21. A fluid collecting sheath comprising: a proximal end having a first diameter; a distal end having a second diameter, wherein the second diameter is greater than the first diameter; a proximal orifice defined in the proximal end, wherein the proximal orifice is configured to selectively expand in width to operably engage an elongated shaft of an endoscope; an outer edge configured to collapse for insertion into a patient's vagina and flex to conform to and create a seal against walls of the patient's vagina; and a fluid line forming a fluid drain at the distal end.
 22. The fluid collecting sheath of claim 21, wherein the proximal orifice is configured to fixedly engage an elongated shaft of an endoscope, such that the fluid collecting sheath and the endoscope are movable in concert with one another.
 23. The fluid collecting sheath of claim 21, wherein the fluid line is configured to couple to a vacuum source.
 24. The fluid collecting sheath of claim 21, further including a collection vessel in fluid communication with the fluid line, wherein the collection vessel is configured to receive fluid captured by the fluid drain.
 25. The fluid collecting sheath of claim 21, further including a collar extending from the fluid line, wherein the collar is configured to be secured to an endoscope.
 26. The fluid collecting sheath of claim 25, wherein the collar is at least partially elastic.
 27. The fluid collecting sheath of claim 21, wherein the fluid collecting sheath and the fluid line are a single integrally formed structure in which the fluid line extends within the fluid collecting sheath between the proximal end and the distal end of the fluid collecting sheath.
 28. The fluid collecting sheath of claim 21, wherein the fluid collecting sheath tapers along its length forming a conical shape.
 29. A system, comprising an endoscope defining a proximal end, a distal end, and an elongated shaft extending between the proximal end and the distal end of the endoscope; and a fluid collecting sheath configured for insertion into a vaginal opening, wherein the fluid collecting sheath includes: a proximal end having a first diameter; a distal end having a second diameter, wherein the second diameter is greater than the first diameter; a proximal orifice defined in the proximal end of the fluid collecting sheath, wherein the proximal orifice is configured to selectively expand in width to operably engage the elongated shaft of the endoscope; an outer edge configured to collapse for insertion into a patient's vagina and flex to conform to and create a seal against walls of the patient's vagina; and a fluid line forming a fluid drain at the distal end of the fluid collecting sheath.
 30. The system of claim 29, further including a vacuum source in fluid communication with the fluid line, wherein the vacuum source is configured to apply negative pressure to the fluid drain to draw fluid through the fluid line.
 31. The system of claim 29, wherein the proximal orifice is configured to fixedly engage the elongated shaft of the endoscope, such that the fluid collecting sheath and the endoscope are movable in concert with one another.
 32. The system of claim 29, further including a collection vessel in fluid communication with the fluid line, wherein the collection vessel is configured to receive fluid captured by the fluid drain.
 33. The system of claim 29, further including a collar extending from the fluid line, wherein the collar is configured to be secured to the endoscope.
 34. The system of claim 33, wherein the collar is at least partially elastic.
 35. The system of claim 29, wherein the fluid collecting sheath and the fluid line are a single integrally formed structure in which the fluid line extends within the fluid collecting sheath between the proximal end and the distal end of the fluid collecting sheath.
 36. The system of claim 29, wherein the fluid collecting sheath tapers along its length forming a conical shape.
 37. A system, comprising an endoscope defining a proximal end, a distal end, and an elongated shaft extending between the proximal end and the distal end of the endoscope; and a fluid collecting sheath defining a proximal end and a distal end, wherein the fluid collecting sheath is configured for insertion into a vaginal opening, wherein the fluid collecting sheath includes: a plurality of distal-facing fluid collecting apertures defined at the distal end of the fluid collecting sheath; a fluid line in fluid communication with the plurality of distal-facing fluid collecting apertures; and a channel configured to selectively expand in width to operably engage the elongated shaft of the endoscope.
 38. The system of claim 37, wherein the channel of the fluid collecting sheath is configured to fixedly engage the elongated shaft of the endoscope therein, such that the fluid collecting sheath and the endoscope move in concert with one another.
 39. The system of claim 37, further including at least one drip flange formed at the distal end of the fluid collecting sheath, wherein the at least one drip flange is configured to direct fluid away from the channel of the fluid collecting sheath.
 40. The system of claim 37, further including a collection vessel in fluid communication with the fluid line, wherein the collection vessel is configured to receive fluid captured by the plurality of distal-facing fluid collecting apertures. 